European Partnership for the Assessment of Risks from Chemicals

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Published July 19, 2023 | Version v1
Journal article Open

Innovative tools and methods for toxicity testing within PARC work package 5 on hazard assessment

Authors/Creators

  • 1. French Agency for Food Environmental and Occupational Health and Safety
  • 2. German Federal Institute for Risk Assessment
  • 3. National Food Institute, Technical University of Denmark
  • 4. INRAE, Toxalim Research Centre in Food Toxicology
  • 5. Université Paris Cité, Inserm unit 1124
  • 6. Department In Vitro Toxicology and Dermato-Cosmetology (IVTD) at the Faculty of Medicine and Pharmacy of the Vrije Universiteit Brussel
  • 7. Helmholtz Centre for Environmental Research, Leipzig, Germany,
  • 8. Department of Organismal Biology, Uppsala University
  • 9. Leibniz Research Institute of Environmental Medicine, Düsseldorf

Description

New approach methodologies (NAMs) have the potential to become a major
component of regulatory risk assessment, however, their actual implementation is
challenging. The European Partnership for the Assessment of Risks from
Chemicals (PARC) was designed to address many of the challenges that exist
for the development and implementation of NAMs in modern chemical risk
assessment. PARC’s proximity to national and European regulatory agencies is
envisioned to ensure that all the research and innovation projects that are initiated
within PARC agree with actual regulatory needs. One of the main aims of PARC is
to develop innovative methodologies that will directly aid chemical hazard
identification, risk assessment, and regulation/policy. This will facilitate the
development of NAMs for use in risk assessment, as well as the transition from
an endpoint-based animal testing strategy to a more mechanistic-based NAMs
testing strategy, as foreseen by the Tox21 and the EU Chemical’s Strategy for
Sustainability. This work falls under work package 5 (WP5) of the PARC initiative.
There are three different tasks within WP5, and this paper is a general overview of
the five main projects in the Task 5.2 ‘Innovative Tools and methods for Toxicity
Testing,’ with a focus on Human Health. This task will bridge essential regulatory
data gaps pertaining to the assessment of toxicological prioritized endpoints such
as non-genotoxic carcinogenicity, immunotoxicity, endocrine disruption (mainly
thyroid), metabolic disruption, and (developmental and adult) neurotoxicity,
thereby leveraging OECD’s and PARC’s AOP frameworks. This is intended to
provide regulatory risk assessors and industry stakeholders with relevant,
affordable and reliable assessment tools that will ultimately contribute to the
application of next-generation risk assessment (NGRA) in Europe and worldwide.

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Additional details

Funding

European Commission
PARC - Partnership for the Assessment of Risks from Chemicals 101057014